IVDR Webinar Series – TÜV SÜD x Entourage
IVDR Webinar Series – TÜV SÜD x Entourage
Surveillance activities and management of the entire IVD life cycle have been one of the main aspects which have been reinforced and sharpened with the introduction of the IVDR in May 2017.
In a collaborative webinar hosted by TÜV SÜD and Entourage, our experts will delve into optimal IVDR Post-Market Surveillance (PMS) strategies. Participants will gain insights into the IVDR PMS concept and on how to master the PMS process in a compliant and efficient manner. Efficiency strategies will be discussed, e.g., how to leverage different PMS deliverables and how to implement this in the Quality Management System.
Join us to get invaluable insights from our world-class experts on how to master the PMS IVDR life cycle concept to ensure continuous supply of safe and state of the art IVDs.
Date: 18 July 2024, Thursday
Time:
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Date |
CET |
Equivalent SGT |
Equivalent EST |
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Session 1 |
Thursday, 18th July |
09:00 – 10:00 AM |
03:00 – 04:00 PM |
03:00 – 04:00 AM |
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Session 2 |
Thursday, 18th July |
03:00 – 04:00 PM |
09:00 – 10:00 PM |
09:00 – 10:00 AM |
Duration: 60 mins (45 mins panel discussion + 15 mins Q&A)
Topic 1: PMS concept under the IVDR – a life cycle approach
Topic 2: Legacy IVDs – do IVDR PMS requirements apply?
Topic 3: Understanding the PMS concept – which deliverables apply?
Topic 4: PMS strategies – utilizing SW technology to leverage?
Conclusion & Q&A
Dr. Heike Möhlig-Zuttermeister (Speaker)
Global Director in-vitro Diagnostics (IVD) & Segment Manager - IVD, TÜV SÜD
Sven Hoffmann (Speaker)
Head of IVD and Principal Consultant, Entourage GmbH
Krystyna Hinder (Moderator)
Director Customer Relationship Management, Pharmaceutical Engineer, TÜV SÜD
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